Kornimate/medical-research-clean huggingface dataset:
surufatinib combined with sintilimab for advanced mss-type colorectal cancer : a phase ii study

Conditions: Advanced Colorectal Cancer

Summary: a phase ii study to assess the efficacy and safety of surufatinib combined with sintilimab as a second-line treatment in patients with advanced mss-type crc.


Eligibility criteria:
inclusion criteria: 1. for inclusion in study, patient must provide a written informed consent. 2. male or female, age18-75 years. 3. pathologically confirmed unresectable locally advanced or advanced mss-type metastatic colorectal adenocarcinoma . 4. the patient had previously failed standard first-line systemic chemotherapy,prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy. 5. eastern cooperative oncology group (ecog) performance status: 0 or 1. 6. life expectancy \> 12 weeks. 7. have measurable disease based on recist 1.1. exclusion criteria: 1. any therapy with anti-pd-1, or anti-pd-l1/l2 antibodies or anti-cytotoxic t lymphocyte associated antigen-4 (ctla-4) antibody (or any other antibody acting on t cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous. 2. prior receipt of surufatinib. 3. history of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type i diabetes who only need insulin replacement therapy). 4. history of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing. 5. any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
efficacy of fibrin sealant in hypospadias surgery

Conditions: Hypospadias

Summary: the aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.

many procedures have been tried for the sake of proper management of hypospadias and reducing the complications. of them, tabularized incised plate (tip) is one of the most convenient technique, which became the most common procedure for hypospadias repair (elsayem et al., 2022). although many surgical modifications and techniques have been prescribed to minimize post-operative complications and improve outcomes, a high percentage of complications still occurs. urethrocutaneous fistulae are the most common post-operative complication (10%-40%) after hypospadias surgery; other complications being skin flap related complications such as flap necrosis, suture line breakdown, ascent of the testis and penile torsion (shenoy et al.,2021). in this thesis a secondary preputial dartos flap will be performed in all cases and we will evaluate the value of usage of fibrin glue on the 1ry suture line .

Eligibility criteria:
inclusion criteria: * inclusion criteria all treatment naïve children with hypospadias. exclusion criteria: * adult hypospadias. * recurrent cases. * prio pelvic trauma or radiation.
micromatrix® flex in tunneling wounds

Conditions: Pressure Injury; Venous Ulcer; Necrotizing Soft Tissue Infection; Diabetic Ulcers; Draining Wound

Summary: to evaluate the safety and performance of micromatrix® flex in subjects with wounds complicated by tunneling and/or undermining features.

the purpose of this study is to evaluate the safety and performance of micromatrix® flex in subjects with wounds complicated by tunneling and/or undermining features. prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 22 years at the time of consent 2. patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the instructions for use 3. patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen 4. patient has reviewed the irb/iec-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the irb/iec-approved consent form exclusion criteria: 1. burn as etiology of wound 2. unmanaged infection and/or osteomyelitis as determined pre-operatively 3. known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other 4. patient report of concurrent participation in another clinical trial that would interfere with this study 5. any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements
efficacy of diclofenac on pain during endometrial sampling

Conditions: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Summary: abnormal uterine bleeding is common in thai women. traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine. pain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor. nsaids, diclofenac potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. because of its cost, easy accessible and easy administration, diclofenac potassium was selected to be used in this study. its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects. the hypothesis of this study is that "diclofenac potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" double blind randomised controlled trial was performed in this study with 45 patients included in each group.


Eligibility criteria:
inclusion criteria: * thai women at the age over 35 years old * presenting with abnormal uterine bleeding and have a plan of performing fractional curettage exclusion criteria: * uterine anomalies * pregnancy * pelvic inflammatory disease * uncontrolled medical conditions * known cases of gynecological diseases such as gynecological malignancy, abnormal pap smear * nsaids allergy * contraindicate to nsaids use
a study to evaluate the efficacy and safety of a vaccine, asp0113, in cytomegalovirus (cmv)-seronegative kidney transplant recipients receiving an organ from a cmv-seropositive donor

Conditions: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

Summary: the purpose of this study was to evaluate the efficacy of asp0113 compared to placebo in reducing the incidence of cytomegalovirus (cmv) viremia in cmv-seronegative subjects receiving a kidney from a cmv-seropositive donor. this study also evaluated the safety of asp0113 in this patient population.

participants were followed for one year after first study drug injection. this was the primary study period. participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

Eligibility criteria:
inclusion criteria: * cmv negative subject having received a cmv seropositive kidney (living or deceased) * participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through randomization. exclusion criteria: * participant underwent a course of cmv-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days. * participant had received from one month prior to transplant or planned to receive cmv immunoglobulin. * participant had cmv viremia or cmv disease from time of transplant until time of randomization.

Keywords: asp0113 cytomegalovirus (cmv) kidney transplantation
survey of procedures and resources for initiating treatment of hiv in africa-malawi

Conditions: HIV; Antiretroviral Therapy

Summary: in its 2017 revision of the global guidelines for hiv care and treatment, the world health organization (who) called for rapid or same-day initiation of antiretroviral treatment (art) for eligible patients testing positive for hiv. however, to date neither the who nor the malawi ministry of health has provided detailed guidance on how to implement this recommendation. in sub-saharan africa, where most hiv patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (arvs). among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for hiv is dispensed an initial supply of medications. there is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. the sprint (survey of procedures and resources for initiating treatment of hiv in africa) study will begin to develop this evidence base. sprint will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated art at the study sites. data will be collected from 12 health facilities in malawi. the survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. the record review for a retrospective cohort of patients eligible for art will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. sprint is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.


Eligibility criteria:
inclusion criteria: * adult patients (at least 18 years old) * tested hiv-positive (or brought proof of positive hiv status) at a study site within the study period (1 july 2018 through 30 june 2019) exclusion criteria: * pregnant
comparison of microfracture treatment and cartipatch® chondrocyte graft treatment in femoral condyle lesions

Conditions: Knee Chondral; Osteochondral Defect

Summary: cartipatch® is an autologous chondrocyte implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. the submitted protocol is a phase iii multicentric, prospective, controlled and randomized clinical trial, sponsored by tbf génie tissulaire, france. the main objective of the protocol is to compare the clinical improvement of the ikdc subjective score between the microfracture-treated group and the cartipatch® chondrocyte graft-treated group , 18 months following surgery. several secondary objectives were determined. the microfracture procedure will be conducted in one operative step, during arthroscopy and cartipatch® procedure will be conducted in two operative steps: 1. arthroscopy to collect cartilage; 2. implantation following arthrotomy about 6 weeks following arthroscopy. both groups will follow the same rehabilitation program.


Eligibility criteria:
inclusion criteria: * isolated femoral osteochondral lesion * aged 18 to 45 * grade 3 or 4 lesion (icrs) sized 2,5 to 7,5cm2 * lesion depth under 10mm * ikdc score below 55 * no prior surgical treatment exclusion criteria: * pregnancy or breastfeeding * allergy * arthrosis * varus or valgus angle greater than 6° * kissing lesion * affection of the patella * excessive laxity * meniscal pathology history * severe chronic disease * bmi \> 30 * hiv, hepatitis b, c, htlv, syphilis
effects of pecs 1 block on venous cancer port catheter

Conditions: Catheter; Pain (Indwelling Catheter)

Summary: in this study our aim is to investigate the effects of ultrasound (usg) guided pectoral block (pecs) type 1 in the administration of an implanted port-a-cath .

cancer is one of the most important reasons of mortality in the world. there are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. however, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. traditionally this implantation is adminstered with infiltrative anesthesia. recently, usg is used in anesthesia practice world wide. blanco r et all (1) defined pecs 1 block as an alternative to paravertebral block. pecs 1 block aims to anesthetize the medial and lateral pectoral nerves. in this study our aim is to investigate the effects of usg guided pecs 1 block in the administiration of an implanted port-a-cath .

Eligibility criteria:
inclusion criteria: * ages between 18- 75 * asa (american society of anesthesiologists) score i-iv * undergoing elective port-a-cath replacemnet exclusion criteria: * patients with neurological deficits * patients who have major vascular damage at the same side * mentally retarded patients * patients with alcohol or drug addiction * patients who are allergic to local anesthetics * pregnancy * paitents with coagulopathy * patients with skin infection at the side of the procedure * patients with pneumothorax at the side of the procedure * patient with a pacemaker
the home blood pressure (bp) trial

Conditions: End Stage Renal Disease on Dialysis

Summary: the main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the seattle and san francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmhg to reduce rates of intradialytic hypotension. the target systolic blood pressure of \<140 mmhg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.

the main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the seattle and san francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmhg in reducing rates of intradialytic hypotension. the target systolic blood pressure of 100-140 mmhg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (esrd) * greater than 3 months since initiation of dialysis * no anticipated change to peritoneal dialysis or kidney transplant within 10 months * life expectancy greater than 10 months * hypertension (defined as mean pre-dialysis sbp \> 140 mmhg over prior 2 weeks or taking bp medications) * able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit) * no condition that the primary nephrologist or pis feel precludes participation exclusion criteria: * incarcerated or institutionalized (prohibits home blood pressure measurement) * participating in another intervention study that may affect blood pressure * pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)

Keywords: blood pressure, dialysis
serum biomarkers in parkinson's disease at different stages

Conditions: Parkinson Disease

Summary: * determine clinical characteristics of parkinsonian patients in various stages of disease; * measure peripheral neurodegeneration, synaptic, and inflammation biomarkers in a population of parkinsonian patients at various stages of disease. * measure vesicular neurodegeneration, synaptic and inflammation biomarkers


Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic pd according to movement disorders society (mds) criteria; * age: 18-80 years; * signature of informed consent to participate in this study exclusion criteria. * women pregnant * inflammatory or autoimmune diseases
fetal cardiac magnetic resonance in detection of chd

Conditions: Congenital Heart Disease; Fetal Cardiac Disorder; Heart Defect, Congenital

Summary: the aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new doppler ultrasound based gating method for the detection of congenital heart desease.


Eligibility criteria:
inclusion criteria: * fetuses in third trimenon * congenital heart defect suspected by obstetric ultrasound exclusion criteria: * pregnant women with contraindication for native mri
lay health coaches for weight loss: peers versus mentors

Conditions: Obesity

Summary: the primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rbwl) + peer health coaches yields significantly greater weight loss than rbwl + mentor health coaches and rbwl alone.


Eligibility criteria:
inclusion criteria: * body mass index between 30 and 40 * age between 40 and 60 years * english speaking exclusion criteria: * are unwilling to communicate regularly with a weight loss coach * report not being able to walk 2 blocks (1/4 mile) without stopping * are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months * are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe * report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the physical activity readiness questionnaire * report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines * report conditions that, in the judgment of the pi, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).

Keywords: obesity weight loss lay health coach peer coach mentor coach reduced intensity weight loss program
a comparative study of pf-06439535 plus paclitaxel-carboplatin and bevacizumab plus paclitaxel-carboplatin patients with advanced non-squamous nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multinational, double-blind, randomized, parallel-group phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-pfizer plus paclitaxel and carboplatin versus bevacizumab-eu plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous nsclc.


Eligibility criteria:
inclusion criteria: * male and female patients age at least 18 years of age, or age of consent in the region. * newly diagnosed stage iiib or iv non-small cell lung cancer (according to revised international system for staging lung cancer criteria of 2010) or recurrent non-small cell lung cancer (nsclc). * histologically or cytologically confirmed diagnosis of predominately non-squamous nsclc. * be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous nsclc. exclusion criteria: * small cell lung cancer (sclc) or combination sclc and nsclc. squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature. * evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed. * known sensitizing egfr mutations (for example, deletion 19 or l858r) or eml4-alk translocation positive mutations. * prior systemic therapy for nsclc; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
intravenous rhmbl in patients with multiple myeloma receiving chemotherapy followed by stem cell transplant

Conditions: Multiple Myeloma

Summary: mbl deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (hsct) for their multiple myeloma. patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhmbl.

mbl deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v. infusions of rhmbl at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious prophylactic therapy alone. a total of 20 patients will be treated in each of the rhmbl arms, and 10 patients will receive best standard supportive prophylactic therapy but not rhmbl. all patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards.

Eligibility criteria:
major inclusion criteria: patients must meet all of the following criteria to be eligible for enrollment into the study: * capable of understanding the protocol requirements and risks and providing written informed consent. * histologically or cytologically confirmed diagnosis of multiple myeloma. * mannose-binding lectin level \<300 ng/ml. * age ≥18 years old. * score of 0 to 2 on the zubrod performance status scale. * patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous hsct for the treatment of multiple myeloma. exclusion criteria: * concurrent serious medical illness that could potentially interfere with protocol compliance. * concurrent or previous malignancy associated with a poor prognosis. * known chronic infectious disease, such as acquired immunodeficiency syndrome (aids) or hepatitis (for hepatitis and human immunodeficiency virus \[hiv\] will not be performed). * positive screening pregnancy test or is breast-feeding. * female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol. * known or clinically suspected active brain metastases. * current participation in another clinical study with an investigational agent and/or use of an investigational drug.

Keywords: multiple myeloma stem cell transplant rhmbl